HydromorphonePhase 4NCT04436224
Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation
A Phase 4 study testing Hydromorphone, Fentanyl and Butorphanol in people with Hydromorphone and Analgesia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression and gastrointestinal motility. The study will further explore the continuous pumping-dose of hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma concentration as well as evaluates the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydromorphone, Analgesia, ICU
- What is being tested?
- Hydromorphone, Fentanyl and Butorphanol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2020to 30 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old;
- Non-mechanical ventilation patients with expected ICU stay time >24h
- People with moderate to severe pain who need immediate analgesic treatment (NRS ≥ 4 or BPS ≥ 5 points, CPOT ≥ 3);
Who cannot join
- During pregnancy or breastfeeding；
- Confirmed acute severe intracranial or spinal nerve disease caused by vascular, infection, intracranial dilation or injury;
- Non-compensatory acute circulatory failure (severe hypotension with MAP<55 mmHg even if sufficient fluid resuscitation and vascular compression therapy);
- Severe bradycardia (heart rate<55 beats/min) or heart block of degree II-III (excluding those with pacemakers installed);
- Unable to obtain pain scores or any other conditions that may seriously interfere with the collection of research data;
- Have used analgesics other than remifentanil during mechanical ventilation in the ICU;
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- Having a history of long-term use of opioid drugs or opioid addiction;
- Known allergy history of experimental drugs;
- Suffering from severe or acute asthma, or respiratory depression caused by severe carbon dioxide retention, head injury, and intracranial damage;
- Danger period intestinal obstruction (present or at risk of progression to gastrointestinal obstruction, especially in patients with paralytic intestinal obstruction);
- Having participated in this study or any other intervention studies (any study that assigns patients to different treatment groups);
- Unsuitable to participate in this experiment according to the judgment of the researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation: A Dose-exploration and Effectiveness Study
Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression and gastrointestinal motility. The study will further explore the continuous pumping-dose of hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma concentration as well as evaluates the safety and effectiveness of hydromorphone for ICU non-mechanical ventilation patients.
- Conditions
- Hydromorphone, Analgesia, ICU
- Being tested
- Hydromorphone, Fentanyl, Butorphanol
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump)
FentanylDrug
Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)
ButorphanolDrug
Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump)
| Study group | Role | What they receive |
|---|---|---|
| hydromorphone | Experimental | NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，loading dose 0.5-2mg，maintenance dose 0.50mg/h Receives: Drug: Hydromorphone |
| Butorphanol | Active comparator | NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，loading dose 0.5-1mg，maintenance dose 0.08-0.2mg/h Receives: Drug: Butorphanol |
| fentanyl | Active comparator | NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，loading dose 1-2mg/kg，maintenance dose 0.7-10mg/kg/h Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful analgesic proportion
Proportion of patients in each group who reached the target analgesia score range
Measured: From date of using the intervention drugs until the date of leaving from icu, up to 28 days
Secondary outcomes (10)
Score
analgesia score, such as CPOT or NRS
Measured: From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
dose of analgesics
total dose of analgesics during the study
Measured: From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
Adverse event
Adverse event during the study, including hypotension.et
Measured: From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days
ICU stay
duration of stay in ICU
Measured: from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.
Days without delirium or coma
Number of days in which the patient did not experience delirium or coma
Measured: From date of using the intervention drugs until the date of discharge or death from any cause, up to 28 days
cost during ICU
Hospitalization expenses during ICU
Measured: from the date of entering hospital until the date of discharging or death from any cause，up to 60 days
Mechanical ventilation-free days
Duration without mechanical ventilation during the use of analgesics
Measured: From date of using the intervention drugs until the date of retrachealing intubation,leaving icu or death from any cause, up to 28 days
Length of hospital stay
Duration from hospital admission to hospital discharge or death, measured in days.
Measured: From hospital admission to hospital discharge or death, assessed up to 60 days.
Mortality rate in hospital
Death from any cause before hospital discharge.
Measured: From hospital admission to hospital discharge or death, assessed up to 60 days.
ICU mortality
Death from any cause before ICU discharge.
Measured: From ICU admission to ICU discharge or death, assessed up to 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start4 Sep 2020
- Primary completion29 Mar 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydromorphoneStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436224
- Sponsor's protocol ID
- NFEC-2020-173
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2020
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation: A Dose-exploration and Effectiveness Study
- ClinicalTrials.gov ID
- NCT04436224
- Acronym / sponsor ID
- NFEC-2020-173
- Conditions
- Hydromorphone, Analgesia, ICU
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 29 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression and gastrointestinal motility. The study will further explore the continuous pumping-dose of hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma concentration as well as evaluates the safety and effectiveness of hydromorphone for ICU non-mechanical ventilation patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hydromorphone | Experimental | Drug: HydromorphoneNS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，loading dose 0.5-2mg，maintenance dose 0.50mg/h |
| Butorphanol | Active comparator | Drug: ButorphanolNS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，loading dose 0.5-1mg，maintenance dose 0.08-0.2mg/h |
| fentanyl | Active comparator | Drug: FentanylNS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，loading dose 1-2mg/kg，maintenance dose 0.7-10mg/kg/h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old;
- Non-mechanical ventilation patients with expected ICU stay time >24h
- People with moderate to severe pain who need immediate analgesic treatment (NRS ≥ 4 or BPS ≥ 5 points, CPOT ≥ 3);
Key exclusion criteria (12 listed)
- During pregnancy or breastfeeding；
- Confirmed acute severe intracranial or spinal nerve disease caused by vascular, infection, intracranial dilation or injury;
- Non-compensatory acute circulatory failure (severe hypotension with MAP<55 mmHg even if sufficient fluid resuscitation and vascular compression therapy);
- Severe bradycardia (heart rate<55 beats/min) or heart block of degree II-III (excluding those with pacemakers installed);
- Unable to obtain pain scores or any other conditions that may seriously interfere with the collection of research data;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydromorphoneIntravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump) | Drug | hydromorphone |
| FentanylIntravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump) | Drug | fentanyl |
| ButorphanolIntravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump) | Drug | Butorphanol |
Primary outcome
successful analgesic proportion
Time frame: From date of using the intervention drugs until the date of leaving from icu, up to 28 days
Proportion of patients in each group who reached the target analgesia score range
10 secondary outcomes
Score
Time frame: From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
dose of analgesics
Time frame: From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days
Adverse event
Time frame: From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days
ICU stay
Time frame: from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.
Days without delirium or coma
Time frame: From date of using the intervention drugs until the date of discharge or death from any cause, up to 28 days
cost during ICU
Time frame: from the date of entering hospital until the date of discharging or death from any cause，up to 60 days
Mechanical ventilation-free days
Time frame: From date of using the intervention drugs until the date of retrachealing intubation,leaving icu or death from any cause, up to 28 days
Length of hospital stay
Time frame: From hospital admission to hospital discharge or death, assessed up to 60 days.
Mortality rate in hospital
Time frame: From hospital admission to hospital discharge or death, assessed up to 60 days.
ICU mortality
Time frame: From ICU admission to ICU discharge or death, assessed up to 60 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone, Fentanyl and Butorphanol in people with Hydromorphone and Analgesia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
successful analgesic proportion (time frame: From date of using the intervention drugs until the date of leaving from icu, up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.